The NanoAssemblr commercial formulation system supports an automated workflow of priming, calibration, formulation, and in-line dilution to simplify GMP manufacturing of mRNA-LNP drug products. Its intuitive software interface enables 21 CFR Part 11 compliance* and electronic batch records that capture in-process monitoring of flow rate and pump speed. Scalable NxGen™ technology and low-pulsation pumps provide precise control of mixing parameters, resulting in consistent flow rates from 6 to 48 L/h that produce homogenous and reproducible nanoparticles. 

The single-use flow path minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover between production runs while minimizing the risk of cross-contamination. The flow kit can be easily installed and ready for formulation in <60 minutes. 

Self-amplifying RNA (saRNA)-LNPs prepared using NxGen technology maintain physicochemical characteristics throughout scale-up to commercial manufacturing. Size, polydispersity index (PDI), and encapsulation efficiency are consistent using A) the NxGen, NxGen 500, and NxGen commercial cartridge 48 L/h and B) from Ignite+ for early preclinical development through to the commercial formulation system for clinical and commercial manufacturing. Error bars are 1 standard deviation and comparison values are from a post-hoc Tukey test after one-way ANOVA.